FDA 510(k)

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent

K-Number: K180469 · 2018-11-06

Decision Date2018-11-06

Product CodeFAD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2018-11-06 under 510(k) number K180469. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent?

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent is a medical device that received FDA 510(k) clearance on 2018-11-06. The listed applicant is Coloplast Corp.. The 510(k) number is K180469.

When did ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent receive FDA 510(k) clearance?

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent received FDA 510(k) clearance on 2018-11-06, under 510(k) number K180469.

Who is the listed applicant for ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent?

The FDA product code for ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent is FAD.

Related Clinical Trials

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Related Devices (Code: FAD)

K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent SetBoston Scientific Corporation K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.